RESOURCES

What it Treats

Erivedge® (vismodegib) capsule is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.

It is not known if Erivedge is safe and effective in children.

Serious Side Effects

Erivedge can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

Important Safety Information

What is the most important information I should know about Erivedge?

Erivedge can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

For females who can become pregnant:

You should talk with your healthcare provider about the risks of Erivedge to your unborn child

Your healthcare provider will do a pregnancy test within 7 days before you start taking Erivedge

In order to avoid pregnancy, you should use birth control during treatment and for 24 months after your final dose of Erivedge. Talk with your healthcare provider about what birth control method is right for you during this time

Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed, or if you become pregnant or think that you may be pregnant

For males:

Erivedge is present in semen. Do not donate semen while you are taking Erivedge and for 3 months after your final dose

You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with Erivedge, and for 3 months after your final dose to protect your female partner from being exposed to Erivedge

Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Erivedge

Exposure to Erivedge during pregnancy:

There is a Pregnancy Exposure Registry for females taking Erivedge who become pregnant. The purpose of this registry is to monitor the health of you and your unborn baby. If you think that you or your female partner may have been exposed to Erivedge during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with Erivedge, you or your healthcare provider should report your pregnancy to Genentech at (888) 835-2555.

What should I tell my healthcare provider before taking Erivedge?

If you are pregnant or plan to become pregnant

If you are breastfeeding or plan to breastfeed. It is not known if Erivedge passes into your breast milk. You should not breastfeed during treatment and for 24 months after your final dose of Erivedge. Talk to your healthcare provider about the best way to feed your baby during this time

About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What should I avoid while taking Erivedge?

Do not donate blood or blood products while you are taking Erivedge and for 24 months after your final dose

Do not donate semen while you are taking Erivedge and for 3 months after your final dose

What are the possible side effects of Erivedge?

Bone growth problems. Bone growth problems have happened in children who have been exposed to Erivedge. These problems may continue even after stopping treatment with Erivedge

The most common side effects of Erivedge are:

Muscle spasms

Hair loss

Change in how things taste or loss of taste

Weight loss

Tiredness

Nausea

Diarrhea

Decreased appetite

Constipation

Joint pain

Vomiting

Erivedge can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of Erivedge. Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be.Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.